FDF / DRUG PRODUCTS in Europe
We can take your pharmaceuticals from lab scale to the early clinical phase and beyond. Our state-of-the-art facility, with GMP-compliant clean rooms, is well equipped to offer a wide range of...
About the plant
Manufacturing, testing and distribution of investigational medicinal products (IMPs) is strongly regulated by the relevant authorities to assure high quality when administered to patients in clinical trials. Full transparency and traceability, from the origin of the starting materials to dosing and the ultimate destruction of the study medication, all in compliance with Good Manufacturing practices (GMP), is mandatory. Maintaining a GMP-certified status for clean rooms requires continuous investment in equipment, facilities and well-trained people.
Certifications
- ISO
- EMA (EU GMP)
Activity
- Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Hard capsules, Terminal sterilization, Fill&Finish, Tubes, Semisolid forms, Small volume vials, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), MHRA (UK), TGA (Australia)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Formulation / Galenic design, Process optimization, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage, Distribution, GDP, CMC regulatory support, IMPD (Investigational Medicinal Product Dossier) submission support
